Docs Await ACA Compliance Rules

Physicians are required to develop and maintain a compliance program in their practice under the Affordable Care Act (ACA), a burden some health policy experts say could be a heavy one for some practices.

However, the federal government has yet to release guidelines on what these compliance programs should look like under the 2010 health reform law, creating conflict for doctors on what to do next.

Section 6401 of the ACA -- an often-forgotten provision -- requires that all providers and suppliers, regardless of their size, institute formal compliance programs. New practices will no longer be able to enroll in Medicare or Medicaid without a compliance program in place, and already existing practices also will be expected to institute them.

The mandate shifts part of the burden of preventing waste, fraud, and abuse from the federal government -- which has traditionally been in a "pay and chase" mode -- to physicians.

"If there's a problem with billing or an error or something was miscoded, the federal government can in the future point to these required compliance programs and say 'You didn't follow even your own required compliance program,'" said Everette James, JD, MBA, director of the Health Policy Institute at the University of Pittsburgh Graduate School of Public Health. "So this does shift the regulatory burden to the practice site from the government."

Before the law, compliance programs were voluntary or strongly recommended, but not required.

But the Department of Health and Human Services (HHS) Office of Inspector General (OIG) has yet to publish formal guidelines on what the programs should look like -- a delay James attributed to the many other key aspects of the ACA the department is gearing up for.

"They're reeling from the lack of state interest in both Medicaid expansion and running the exchanges, and so you're seeing delay in a lot of the implementation of the Affordable Care Act and this is another example," James said.

"Everyone thinks that they're just going to follow the compliance program guidelines that have been in place since the fall of 2000," said Sheppard, who runs First Healthcare Compliance in Wilmington, Del. "We don't expect any great variation."

The 2000 guidelines offered seven components on which to base programs, including:

James and Sheppard agreed this could create a significant burden on small practices.

"In order to create an effective compliance program, there are a lot of resources needed," Sheppard said, adding some places like hospitals have staff entirely devoted to the issue.

Some key elements she recommended practices focus on include having an adequate training program, conducting at least annual self-audits, and drafting policies and procedures to be put in place.

But James and Sheppard disagree on how practices should proceed next.

"It really doesn't make sense to wait for the government to impose the deadline on you," Sheppard said, noting that having a compliance program is a mitigating factor when the government imposes fines or corporate integrity agreements on providers suspected of fraud.

Sheppard points to the increasing enforcement, particularly with small practices and HIPAA, as reasons to act now.

"We know that with the Affordable Care Act task forces have been formed and audits are increasing," she said. "To me, the risks are clear, and it's just a matter of trying to be proactive."

James recommends practices wait until HHS releases further guidelines before they start trying to develop their own programs. However, he agrees that practice administrators can get an idea of what HHS will require by looking at what the agency said in 2000 when the programs were voluntary.

"The guidance that HHS is going to put out related to these formal compliance programs has already been written over the years by the Office of Inspector General integrity program," James told MedPage Today in a video interview. "I would just recommend if practices have an administrator who is interested in looking at how to structure this compliance program that they look at these OIG reports and guidance that's already been provided."

David Pittman is MedPage Today’s Washington Correspondent, following the intersection of policy and healthcare. He covers Congress, FDA, and other health agencies in Washington, as well as major healthcare events. David holds bachelors’ degrees in journalism and chemistry from the University of Georgia and previously worked at the Amarillo Globe-News in Texas, Chemical & Engineering News and most recently FDAnews.

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